MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INBONE TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number SEE H10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Joint Swelling (2356)

Event Date 04/21/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device was not identified, therefore, the manufacturer cannot determine the suspect device.However, the suspect devices in use are part # 200009902, lot 1652006; part # 200010902, lot 1646689; part # 200011902, lot 1647020; part # 220220903, lot 1625961; part # 220224310e, lot 1637826; and part # 220222904, lot 1629002.Manufacture date for lot 1652006 is 05/03/2019; manufacture date for lot 1646689 is 02/13/2019; manufacture date for lot 1647020 is 02/22/2019; manufacture date for lot 1625961 is 1637826; manufacture date for lot 1637826 is 03/23/2019; manufacture date for lot 1629002 is 06/15/2018.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the patient reported having swelling and pain in the ankle.The patient was admitted to er and then scheduled for i/d with possible implant removal based on cultures and needle aspiration.Needle aspiration was suspect so proceeded with implant removal.

• Brand Name: INBONE TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington, tn
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington, tn
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, tn
• MDR Report Key: 10074621
• MDR Text Key: 191551479
• Report Number: 1043534-2020-00094
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEE H10
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: POLY; STEM TIBIAL BASE; STEM TIBIAL MID; STEM TIBIAL TOP; TALAR DOME SZ 3; TIBIAL TRAY
• Patient Outcome(s): Required Intervention